EU GMP Annex 1: Understanding the new regulatory requirements

May 05, 2023

In 2023, the EU released updates to their Annex 1 Guidance Document for the first time since 2009. As such, the road map for sterile drug manufacturers to follow in order to ensure that their products are safe and regulatorily compliant has changed. Register to download this whitepaper to…

  1. Understand the changes being made with the newest updates to EU GMP Annex 1, and the impact they will make on the pharmaceutical industry beyond Europe.
  2. Read about the ways in which manufacturers will need to employ Quality Risk Management (QRM) practices in order to remain compliant with the newest updates.
  3. Learn 7 key considerations for moving from the EU Annex 1 2009 to the 2023 updates
  4. Determine what strategies manufacturers should employ when updating their current processes to remain compliant with Annex 1
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